Infection with measles, mumps or rubella MedDRA version: 20.0 Level: LLT Classification code 10036654 Term: Prevention System Organ Class: 100000004865
Conditions
Interventions
Trade Name: MMRvaxpro
Product Name: MMRvaxpro
Product Code: J07BD52
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous us
Sponsors
The Danish National University Hospital "Rigshospitalet"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gestational age of 32+ weeks, birth weight of 1000+ grams, signed informed consent from the parents. Are the trial subjects under 18? yes Number of subjects for this age range: 6500 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Immune-deficiency (primary or acquired) or –suppression, and/or intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy), signs of severe illness or major malformation, no Danish-speaking parent. Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded. Children with known fructose intolerance, thrombocytopenia or any coagulation disorder will be excluded. Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded. Further, children are excluded from the trial if any contraindication is suspected: history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin. Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim in relation to the specific effect of the MMR vaccine. Sub-group study among 500 children. 1. To measure the level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test at inclusion, 1 month after experimental MMR vaccination at 6 months of age, and again 1 month after the MMR booster scheduled at 15 months of age. Aim in relation to the potential non-specific, heterologous effect of the MMR vaccine. 6426 children. 2. To test if MMR administered to healthy Danish children at 6 months of age decreases non-measles childhood morbidity defined as hospitalisation for infection between 6 and 12 months of age before the third DTaKPHib is scheduled according to the Danish child vaccination programme. ;Secondary Objective: To study immunogenicity defined as measles-mumps-rubella IgG, IgM and cellular immuneresponse after MMR at 6 months To study the associations between child and maternal stress and immuneresponse and morbidity in the child after MMR at 6 months To study the associations between markers of pollution in the child and immuneresponse and morbidity in the child after MMR at 6 months ;Primary end point(s): 1. Level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test 1 month after experimental MMR vaccination at 6 months of age. Level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test at inclusion will be taken into consideration when reporting this primary outcome. 2. Hospitalisation for infection between 6 and 12 months of age (after the second and before the third routine DTaKPHib vaccine) defined by data obtained from The Danish National Patient Register (45;46). ;Timepoint(s) of evaluation of this end point: 1. 7 months of age. 2. 12 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.1 Level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test 1 month after routine MMR vaccination at 15 months of age. 1.2 Level of specific immunity, measured as level of IgG and IgM against measles 1 month after experimental MMR vaccination at 6 months of age. 1.3 IgM and IgG against mumps and rubella 1 month after experimental MMR vaccination at 6 months of age, and again at 1 month after routine MMR vaccination at 15 months of age. 1.4 The associations between level of maternal specific immunity against measles, mumps and rubella and the children’s specific immunity against measles, mumps and rubella will be studied. 2.1 Use of antibiotics defined by data obtained from The Danish Register of Medicinal Product Statistics. 2.2 Atopic disease defined by data from The Danish National Patient Register and The Danish Register of Medicinal Product Statistics. 3.1 Measles, mumps and rubella-specific cellular immunity (T-cells) inclusive T-cell epitope specificity at base-line (randomisation), 1 month after experimental MMR vaccination at 6 months of age, and again at 1 month after routine MMR vaccination at 15 months of age. 3.2 Hyman leucocyte antigen (HLA)-typing of the children using buccal swaps since HLA-typing is prerequisite to define the MMR-specific cellular immunity. 4.1 The influence of acute maternal and child stress levels (salivary cortisol and salivary alpha-amylase) on specific immunity measured as level of IgG and IgM against measles 1 month after experimental MMR vaccination at 6 and 15 months of age. 4.2 The influence of chronic maternal and or child stress levels (hair cortisol) on specific immunity measured as level of IgG and IgM against measles 1 month after experimental MMR vaccination at 6 and 15 months of age. 5.1 The influence of maternal levels of perfluoroalkyl substances (PFASs) on specific immunity measured as level of IgG and IgM against measles | — |
Countries
Denmark
Contacts
Public ContactThe Child and Adolescent Clinic
The Danish National University Hospital "Rigshospitalet"
Outcome results
None listed